CRA ACRP EXAM REVIEW SOLVED QUESTIONS COMPLETE ANSWERS GRADED A PLUS
Question:
What should be the first consideration when conducting a clinical trial?
Answer:
Subject welfare
Question:
When is the investigator allowed to deviate from the protocol?
Answer:
When there is an immediate hazard to a patient.
Question:
If the investigator wanted to deviate from the protocol for an immediate hazard to a patient,
according to ICH E6 guidelines who world they need to report the deviation and rationale to, if
appropriate?
Answer:
- The Sponsor IRB/IEC Regulatory Authorities
Question:
Which conditions should be fulfilled when enrolling a subject into your trial?
Answer:
- Subject meets all inclusion criteria Subject has given written informed consent
Question:
,You've been delegated to handle the storage and inventory of IP. The study drug must be stored
below 25C/77F. On a summer Monday morning you discover that the temperature recording
machine in the storage room has failed so you doin't know what the temperature has been over the
weekend. You check the current temperature; it's 24C/75F. What should you do?
Answer:
- Contact the Sponsor, explain what happened and ask for instructions Set up a site staff meeting to
conduct a root cause analysis
Question:
A protocol amendment was issued for a trial. Your site received IRB approval for the amendment
and wants to implement the increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegated consenting duties you must re-consent trial subjects before
being able to administer the adjusted dose. You decide to only re- consent trial subjects who are still
taking the IP and not from the subjects woh already completed their drug intake period. Is this
allowed according the E6 Guideline for GCP?
Answer:
No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to
the protocol.
Question:
A trial subject informs you she no longer wants to participant in the trial. What should your course
of action be?
Answer:
You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude
the subject from the trial immediately.
Question:
A patient cannot recall the name of the heart condition medication he took a few years ago. This is
important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC).
What's your best course of action?
Answer:
,You attempt to retrieve the patients medical history by contacting previous caregivers and you wait
for additional information before enrollment.
Question:
Who has ultimate trial responsibility for each subject?
Answer:
The principle investigator.
Question:
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the
IRB?
Answer:
No
Question:
What statements are true concerning an adverse drug reaction?
Answer:
- All noxious and unintended responses to a medicinal product related to any dose should be
considered as an ADR An ADR suggests a relationship to trail medication All ADRs must be
documented
Question:
What Adverse Events (AEs) are Serious Adverse Events (SAEs)?
Answer:
- Any AE that results in death Any AE that results in inpatient hospitalization Any AE that is a
congenital anomaly
Question:
, During a study visit a patient tells the investigator that she visited an emergency room and received
intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only
three hours, the investigator did not assess the event as serious. Is this a correct assessment?
Answer:
No, this would be a medically important event and should be considered serious
Question:
What data points minimally need to be reported by the site when reporting an SAE, so that the
sponsor can process the event?
Answer:
Identification of event, product, and trial subject
Question:
During a visit with investigator, a subject reported feeling heart palpitations for a brief period of
time during the previous evening. The heart palpitations resolved without reoccurrence. The
investigator considered these symptoms to be unrelated to study drug. The next day, the subject told
a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found
dead. A preliminary report from the medical examiner indicated the subject died of pulmonary
embolism. What should your next course of action be?
Answer:
- Record these events in case report form Immediately notify sponsor about serious adverse events
Question:
When asked by a regulatory body why they received SAE related information on 12/2013 from an
incident that occurred in 5/2013, the sponsor explained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the
investigator accountable for their late reporting?
Answer:
No, the sponsor should support the conduct QC activities with the sites to help them ensure timely
SAE reporting.
Question:
What should be the first consideration when conducting a clinical trial?
Answer:
Subject welfare
Question:
When is the investigator allowed to deviate from the protocol?
Answer:
When there is an immediate hazard to a patient.
Question:
If the investigator wanted to deviate from the protocol for an immediate hazard to a patient,
according to ICH E6 guidelines who world they need to report the deviation and rationale to, if
appropriate?
Answer:
- The Sponsor IRB/IEC Regulatory Authorities
Question:
Which conditions should be fulfilled when enrolling a subject into your trial?
Answer:
- Subject meets all inclusion criteria Subject has given written informed consent
Question:
,You've been delegated to handle the storage and inventory of IP. The study drug must be stored
below 25C/77F. On a summer Monday morning you discover that the temperature recording
machine in the storage room has failed so you doin't know what the temperature has been over the
weekend. You check the current temperature; it's 24C/75F. What should you do?
Answer:
- Contact the Sponsor, explain what happened and ask for instructions Set up a site staff meeting to
conduct a root cause analysis
Question:
A protocol amendment was issued for a trial. Your site received IRB approval for the amendment
and wants to implement the increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegated consenting duties you must re-consent trial subjects before
being able to administer the adjusted dose. You decide to only re- consent trial subjects who are still
taking the IP and not from the subjects woh already completed their drug intake period. Is this
allowed according the E6 Guideline for GCP?
Answer:
No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to
the protocol.
Question:
A trial subject informs you she no longer wants to participant in the trial. What should your course
of action be?
Answer:
You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude
the subject from the trial immediately.
Question:
A patient cannot recall the name of the heart condition medication he took a few years ago. This is
important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC).
What's your best course of action?
Answer:
,You attempt to retrieve the patients medical history by contacting previous caregivers and you wait
for additional information before enrollment.
Question:
Who has ultimate trial responsibility for each subject?
Answer:
The principle investigator.
Question:
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the
IRB?
Answer:
No
Question:
What statements are true concerning an adverse drug reaction?
Answer:
- All noxious and unintended responses to a medicinal product related to any dose should be
considered as an ADR An ADR suggests a relationship to trail medication All ADRs must be
documented
Question:
What Adverse Events (AEs) are Serious Adverse Events (SAEs)?
Answer:
- Any AE that results in death Any AE that results in inpatient hospitalization Any AE that is a
congenital anomaly
Question:
, During a study visit a patient tells the investigator that she visited an emergency room and received
intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only
three hours, the investigator did not assess the event as serious. Is this a correct assessment?
Answer:
No, this would be a medically important event and should be considered serious
Question:
What data points minimally need to be reported by the site when reporting an SAE, so that the
sponsor can process the event?
Answer:
Identification of event, product, and trial subject
Question:
During a visit with investigator, a subject reported feeling heart palpitations for a brief period of
time during the previous evening. The heart palpitations resolved without reoccurrence. The
investigator considered these symptoms to be unrelated to study drug. The next day, the subject told
a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found
dead. A preliminary report from the medical examiner indicated the subject died of pulmonary
embolism. What should your next course of action be?
Answer:
- Record these events in case report form Immediately notify sponsor about serious adverse events
Question:
When asked by a regulatory body why they received SAE related information on 12/2013 from an
incident that occurred in 5/2013, the sponsor explained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the
investigator accountable for their late reporting?
Answer:
No, the sponsor should support the conduct QC activities with the sites to help them ensure timely
SAE reporting.
